It’s been clear for many years now that some drug companies are abusing the “restricted distribution” idea to keep generic competitors from being able to enter their markets. That, in fact, was a basic part of Martin Shkreli’s entire business plan, but guess what? He was not the first person to think of doing that, and the practice continues in ways that don’t make the gaudy headlines that he did. The idea is that a generic company must show that their product is equivalent to the marketed (off-patent) drug in order to receive FDA approval. But what if they just absolutely can’t get any of it to run the trial? This is where companies set up a “closed distribution” system, which was designed to deal with potentially hazardous compounds that (for example) must be kept away from pregnant female patients (the FDA’s Risk Evaluation and Mitigation Strategy, REMS). But in this case, it’s used to keep the drug away from generic competitors, who basically have no recourse at that point.
I’ve been yelling about this for some time, as have plenty of other people, and I’m very happy to see that Scott Gottlieb of the FDA is taking the problem seriously and trying to take action. The agency has started by publicly identifying the companies that are gaming the system in this way described above. And now they’re addressing another REMS problem – when a generic competitor does manage to try to enter a market for a compound that’s under this system, the FDA wants both of the drugs (naturally enough) to be under the same REMS. But that requires negotiation between the original manufacturer and the generic firm, which gives another opportunity for foot-dragging. The agency is both clarifying the shared-REMS situation and now allowing for waivers when necessary in order to get generics to market in a more timely fashion. And good for them. As the agency says: “Our safety programs shouldn’t be leveraged as a way to forestall generic entry after lawful IP has lapsed on a brand drug. Our market-based system for rewarding innovation is dependent on this kind of legal competition.”
But while we’re talking regulatory affairs and the FDA, there’s another item that needs to be mentioned. The “right-to-try” legislation I wrote about the other day has indeed been signed into law. And I will again publicly predict that it will do virtually nothing for critically ill patients, while opening the door even wider to abusing them for profit (now under the cover of law). But what I wanted to note was an incident yesterday.
The FDA itself issued a press release on the signing of the bill, saying that “Our implementation of the Right to Try Act will build on our long-standing efforts to help patients and families who are facing life-threatening diseases or conditions, in a way that seeks to protect their autonomy, their safety, and the safety of others following in their paths.” Gottlieb himself has mentioned that new policies might have to be written to deal with the law as written. But Sen. Ron Johnson of Wisconsin (an author of the bill) detects a hidden agenda in that sort of language. He has sent an open letter to Scott Gottlieb and the agency, making his intent as clear as possible:
“This law intends to diminish the FDA’s power over people’s lives, not increase it. It is designed to work within existing FDA regulations, definitions, and approval processes. It is not meant to grant FDA more power or enable the FDA to write new guidance, rules, or regulations that would limit the ability of an individual facing a life-threatening disease from accessing treatments.”
Just in case you were wondering. He’s also asking to meet personally with Gottlieb as soon as possible so he can hammer these points home a bit more, which sounds like fun. But I find Senator Johnson’s faith in our drug-discovery abilities touching and a bit embarrassing. He really does seem to believe that there are all sorts of cures that are just being stifled by masses of regulation, and that he’s really connecting desperately ill people with the medicines that they just haven’t been able to get until now. That isn’t true, but it’s pretty to think so, isn’t it? At the signing ceremony, the President made his own views quite clear:
“Thousands of terminally ill Americans will finally have hope, and the fighting chance, and I think it’s going to better than a chance, that they will be cured, they will be helped. . .”
Of all the concepts and facts I would like to see the President grasp, I will admit that those relating to drug discovery and development are rather far down the list. But still. What are people going to do when this law has been on the books for a while with no real effects? Or no real effects but bad ones? Does Scott Gottlieb (or his successor) get hauled in to explain why? Or (a more likely outcome), does no one ever bother to go back and check on anything after having taken their victory laps?
Update: changed to put Senator Johnson from the correct W-state.